Aurinia Pharmaceuticals Inc., a late-stage clinical biopharmaceutical company focused on advancing voclosporin across multiple indications, announced that the FDA has accepted the filing of its New Drug Application (NDA) for voclosporin, as a potential treatment for lupus nephritis (LN), a serious inflammation of the kidneys caused by the autoimmune disease systemic lupus erythematosus (SLE).
The FDA has granted Priority Review for the NDA, which provides an expedited six month review, and has assigned a Prescription Drug User Fee Act (PDUFA) target action date of January 22, 2021. The FDA has also informed the Company that they are not currently planning to hold an advisory committee meeting to discuss the application. The FDA has the option to change this decision based on review of the pending NDA.
The NDA for voclosporin is supported by data from a substantial global clinical program including two pivotal studies, Phase III AURORA and Phase II AURA-LV. Additional AURORA study data was recently presented at the EULAR and ERA-EDTA virtual conferences, which provided further supportive detail into pre-specified subgroup analyses and changes in kidney function.